FLACS vs Phaco in Shallow Anterior Chamber

Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery (FLACS) and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber

Phacoemulsification in eyes with a shallow anterior chamber (ACD < 2.2mm) presents with problems of safe access to the cataract and increased vulnerability of the endothelium and a higher tendency of complications such as descemet's detachment and iris prolapse. A shallow anterior chamber is also responsible for the high incidence of glaucoma and postoperative complications after cataract surgery. Femtosecond assisted cataract surgery has made cataract surgery safer and more predictable. The effective phacoemulsification time and intra-operative manipulation is greatly reduced in FLACS. However phacoemulsification still remains the most widely performed cataract surgery around the world. Post-operative outcomes after phacoemulsification in patients having shallow anterior chamber have been extensively reported in literature over the years.

There is no head to head comparison in terms of intraoperative performance and post-operative outcomes between FLACS and phacoemulsification in eyes with shallow anterior chamber.

The aim is to compare the intra-operative performance and post-operative outcomes in eyes undergoing femtosecond laser assisted cataract surgery versus eyes undergoing phacoemulsification in eyes having shallow anterior chamber.

The study will bring an understanding on the question: Do patients undergoing Femtosecond laser assisted cataract surgery behave differently from those undergoing phacoemulsification?

Study Overview

• Status: Completed
• Conditions: Cataract Surgery; Shallow Anterior Chamber; Phacoemulsification
• Intervention / Treatment: Procedure: Phacoemulsification Cataract SUrgery; Procedure: Femtosecond Cataract Surgery

Detailed Description

Inclusion Criteria:

• Age-related cataract
• Shallow Anterior Chamber (<2.5mm)

Exclusion Criteria:

-Ocular co-morbidity - corneal disorders, glaucoma, uveitis, previous ocular surgery

Surgical Technique :

• Standardized, Single Surgeon
• 2.2 mm clear corneal temporal incision
• FLACS Group : Capsulorhexis, Lens Fragmentation with femto laser

The investigators will be evaluating the following parameters:

1. Primary outcome measure Corneal thickness on day 1, week 1 and 1 month (Change in corneal thickness of 15% from preop. will be considered significant).

2. Secondary outcome measures

   • Corneal clarity -on day 1, week 1 and 1 month postoperatively
   • Anterior chamber cells and flare (Hogan's criteria)
   • Percentage change in endothelial cell density from preoperatively to 3 months postoperatively
   • Unaided visual acuity (distance) on day 1 and 1 month.
   • Best corrected distance visual acuity 1 month postoperatively
3. Other Observations :

1) Cumulative Dissipated Energy (CDE) 2) Surgical time 3) Fluid used 4) Descemets membrane detachment during surgery 5) Incidence of iris trauma 6) Any other intra-operative complications

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380052
      • Iladevi Cataract & IOL Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• uncomplicated, age related cataracts
• Shallow anterior chamber (measured as </=2.5mm )

Exclusion Criteria:

• Coexisting ocular morbidity,
• inability to come for followup

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phacoemulsification Cataract Surgery; Procedure / Surgery : Phacoemulsification Surgery	Procedure: Phacoemulsification Cataract SUrgery; Phacoemulsification in eyes with shallow anterior chamber (<2.5mm depth)
Active Comparator: Femtosecond Cataract Surgery; Procedure / SUrgery - Femtosecond Laser Cataract surgery	Procedure: Femtosecond Cataract Surgery; Femtosecond Cataract Surgery in eyes with shallow anterior chamber < 2.5mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Corneal Thickness	Central Corneal Thickness	Postoperative Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Chamber Inflammation	Anterior chamber cells and flare (Hogan's criteria)	Postoperative Day 1
Endothelial Cell Morphology	Endothelial Cell Density	Postoperative 6 months

Collaborators and Investigators

• Sponsor: Iladevi Cataract and IOL Research Center
• Investigators: Principal Investigator: Abhay Vasavada, MS,FRCS, Iladevi Cataract & IOL Research Centre, Ahmedabad

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: FLACS; Phaco; Shallow Anterior Chamber
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: FLACS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No